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List of Drug Master Files (DMF) of Dienogest Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Hubei Gedian Humanwell Pharmaceutical (1)

02 Bayer AG (1)

03 Gedeon Richter (1)

04 Industriale Chimica s.r.l. (1)

05 LABORCHEMIE APOLDA GMBH (1)

06 Lupin Ltd (1)

07 Olon S.p.A (1)

08 Qinhuangdao Zizhu Pharmaceutical Co., Ltd. (1)

09 Sterling Spa (1)

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01 DIENOGEST (8)

02 DIENOGEST (MICRONIZED) (1)

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01 China (2)

02 Germany (2)

03 Hungary (1)

04 India (1)

05 Italy (3)

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01 Active (6)

02 Inactive (3)

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01 Blank (9)

URL Supplier Web Content
14014
Active
1999-02-26
N/A
II
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24479
Inactive
2010-12-21
N/A
II
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URL Supplier Web Content
23428
Active
2010-01-05
N/A
II
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25251
Active
2011-08-14
N/A
II
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URL Supplier Web Content
24513
Inactive
2011-03-31
N/A
II
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25193
Inactive
2011-06-01
N/A
II
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28680
Active
2014-09-25
N/A
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37039
Active
2022-04-06
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Looking for 65928-58-7 / Dienogest API manufacturers, exporters & distributors?

Dienogest manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dienogest API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dienogest manufacturer or Dienogest supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dienogest manufacturer or Dienogest supplier.

PharmaCompass also assists you with knowing the Dienogest API Price utilized in the formulation of products. Dienogest API Price is not always fixed or binding as the Dienogest Price is obtained through a variety of data sources. The Dienogest Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dienogest

Synonyms

65928-58-7, Dienogestrel, Dienogestril, Sts 557, Endometrion, Dienogestum

Cas Number

65928-58-7

Unique Ingredient Identifier (UNII)

46M3EV8HHE

About Dienogest

Dienogest is an orally-active, semisynthetic, fourth generation, nonethinylated progestogen with antiproliferative, antiandrogenic, anti-inflammatory and antiangiogenic activities that is used in hormone therapy and as a female contraceptive. Upon oral administration, dienogest binds intracellular progesterone receptors which then translocate to the nucleus where the drug-receptor complex interacts with progesterone response elements, thus altering the expression of target genes. Dienogest reduces the production of estradiol, prevents ovulation and alters the cervical mucus and endometrium. In addition, dienogest appears to suppress the expression of cell cycle regulator cyclin D1. Altogether, this may prevent the growth of endometrial epithelial cells and may reduce symptoms associated with leiomyoma.

Dienogest Manufacturers

A Dienogest manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dienogest, including repackagers and relabelers. The FDA regulates Dienogest manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dienogest API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Dienogest manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dienogest Suppliers

A Dienogest supplier is an individual or a company that provides Dienogest active pharmaceutical ingredient (API) or Dienogest finished formulations upon request. The Dienogest suppliers may include Dienogest API manufacturers, exporters, distributors and traders.

click here to find a list of Dienogest suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Dienogest USDMF

A Dienogest DMF (Drug Master File) is a document detailing the whole manufacturing process of Dienogest active pharmaceutical ingredient (API) in detail. Different forms of Dienogest DMFs exist exist since differing nations have different regulations, such as Dienogest USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dienogest DMF submitted to regulatory agencies in the US is known as a USDMF. Dienogest USDMF includes data on Dienogest's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dienogest USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dienogest suppliers with USDMF on PharmaCompass.

Dienogest Manufacturers | Traders | Suppliers

Dienogest Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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